The following coding and billing guidance is to be used with its associated Local coverage determination.
The Abbott RealTime IDH1 by Abbott Molecular is the only test that has received FDA approval to be used as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-1(IDH1) mutation for treatment with TIBSOVO® (ivosidenib).
TIBSOVO® (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test.
Abbott RealTime IDH1 by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 7/20/2018.
The Abbott RealTime IDH2 by Abbott Molecular is the only test that has received FDA approval to be used as an aid in identifying acute myeloid leukemia (AML) patients with an isocitrate dehydrogenase-2 mutation for treatment with enasidenib (IDHIFA®).
IDHIFA is an isocitrate dehydrogenase-2 inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.
Abbott RealTime IDH2 by Abbott Molecular meets the reasonable and necessary criteria for Medicare reimbursement, effective 8/1/2017.
Select the CPT 81120 for claims on or after 7/20/2018.
To report an Abbott RealTime IDH2 service, please submit the following claim information:
- Select the CPT code 81121 for claims on or after 1/1/2018.
- Enter 1 unit of service (UOS)
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part B claim field/types:
- Loop 2400 or SV101-7 for the 5010A1 837P
- Box 19 for paper claim
- Enter the appropriate DEX Z-Code™ identifier adjacent to the CPT code in the comment/narrative field for the following Part A claim field/types:
- Line SV202-7 for 837I electronic claim
- Block 80 for the UB04 claim form
- Select the appropriate ICD-10-CM code
Note: This MolDX coverage determination and coding guideline ONLY applies to the UNMODIFIED, IDH2 test kit by Abbott Molecular for patients with acute myeloid leukemia. If a lab modifies these tests, a MolDX Technical Assessment, outlined in the MolDx section on www.PalmettoGBA.com/medicare, must be submitted and a determination assessed prior to claims submission.
This article reflects the FDA-approved indications on article creation date. MolDX will allow future FDA approved and amended indications for these tests.